Exercise in Sjogren, Myositis and Takayasu's Arteritis

Myositis Clinical Trial

Official title:

Effects of Exercise Training in Primary Sjogren´s Syndrome, Myositis and Takayasu's Arteritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01501019
• Other study ID #: Exercise in Autoimmunity
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2011
• Last updated: February 17, 2016
• Start date: October 2011

Study information

• Verified date: February 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Exercise may improve physical capacity and health parameters in Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.

Therefore, this study aims to investigate the role of an exercise training program in patients with Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Physically inactive

• Stable drugs regime for at least three months

Exclusion Criteria:

• Other rheumatic diseases

• Physical disability that prevent the patient to perform the physical tests

• Severe pulmonary disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myositis
• Primary Sjogren´s Syndrome
• Sjogren's Syndrome
• Takayasu Arteritis

Intervention

Other:
• Exercise training
"Sjöegren arm": 30-60 minutes of combined aerobic and strength exercises, twice a week, moderate intensity. "Myositis arm": 30 minutes of resistance training combined partial blood flow restriction, twice a week, low intensity. "Takayasu's arteritis arm": 30-50 minutes of aerobic, twice a week, moderate intensity.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo School of Medicine Clinical Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic Capacity	Maximum Oxygen Consumption (VO2Max)	Twelve weeks	No
Primary	Muscle strength		Twelve weeks	No
Primary	Quality of life		Twelve weeks	No
Secondary	Serum anti-inflammatory cytokines	Interleukin-10	Twelve weeks	Yes
Secondary	Serum pro-inflammatory cytokines	Interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a)	Twelve weeks	Yes
Secondary	Serum inflammatory markers	erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), aldolase	Twelve weeks	Yes